Commission proposes new rules for plant
protection products

New harmonised EU rules for plant protection products, which aim to
reinforce the protection of public health and and the environment, support
sustainable development in agriculture, reduce animal testing, boost
competitiveness for producers and increase availability of plant protection
products for farmers, have been proposed by the European Commission today. Among
the measures set out in the draft Regulation are shorter and clearer
authorisation criteria and streamlined procedures, simplified data protection
rules, provisions for the substitution of active substances with safer
alternatives and a reduction in testing on vertebrate animals. The proposed
legislation will also strengthen the internal market in this area by allowing
mutual recognition of of plant protection product authorisations between Member
States within the same defined zone. Today’s proposal follows extensive
consultations with Member States and stakeholders over the past 5 years, as well
as a comprehensive impact assessment.

Markos Kyprianou, Commissioner for Health and Consumer Protection, said,
“The proposed Regulation aims to strengthen and improve the rules on
pesticides throughout the EU, to the benefit of EU citizens and stakeholders. It
will ensure an even higher level of protection for human and animal health and
the environment, while also offering more choice to farmers and boosting
competitiveness for the industry in this field.“

Simplifying and harmonising

The proposed Regulation aims to streamline and simplify the authorisation
procedures for plant protection products, and reduce the administrative burden
for all stakeholders. The time-span for the approval of active substances is
shortened, with strict deadlines laid out for Member States, the European Food
Safety Authority and the Commission. Authorisations of active substances will no
longer have to be renewed every 10 years (just once, after the first 10 year
period), in order to avoid a backlog of unnecessary applications which have
already been found to be acceptable for use. However, a review of an
authorisation can still be carried out at any time if new concerns arise about
its safety.

The EU will be divided into 3 zones with similar climatic and ecological
features, and plant protection products authorised by any one Member State will
automatically be cleared for use in the other Member States in that particular
zone. This will help to avoid duplication of work, speed up decision-making and
ensure a more harmonised availability of plant protection products in the
different Member States. National authorities will still be allowed, however, to
impose specific national risk mitigation measures if deemed necessary. Data
protection rules are also simplified, to allow more transparency, greater
competition and a level playing field for small and medium sized producers,
while ensuring that this does not hamper innovation.

Protecting human health, animal welfare and the environment

The proposal put forward by the Commission today will increase the level of
protection given to human health, animal welfare and the environment, through a
series of new provisions. Firstly, the safety evaluations of active substances
will be founded on strict criteria, also based on health considerations and the
effects on the environment (e.g. persistence in the environment). The European
Food Safety Authority (EFSA) has a central role in the evaluation procedure,
which is clearly defined in the proposed Regulation. Control measures are
reinforced in the Commission’s proposal, and farmers and other
professional users will have to keep records of their use of plant protection
products. These will have to be made available on request to the drinking water
industry and neighbours.

In line with the EU’s overall strategy for the sustainable use of
pesticides, the proposed Regulation promotes comparative assessment and
substitution of certain plant protection products with other substances
identified as a safer and viable alternative. The proposed Regulation also
introduces a new rule prohibiting the duplication of tests on vertebrate
animals, which should reduce animal testing and improve animal welfare in this
area.

Next steps

The proposed Regulation is fully in line with the overall Commission strategy
on pesticides, and will complement the Commission’s proposal for a
Directive on the sustainable use of pesticides. It will now be submitted to
Council and the European Parliament for adoption. It is foreseen that it will
enter into effect in 2008, at a time when the current review of all existing
active substances already on the market will have been completed.